Checklist Phase 2 - Process Management

Has the laboratory formulated clear and specific sample acceptation/rejection criteria for each type of sample used by the laboratory, leaving no room for interpretation?

Activity

Does the laboratory have an SOP for Sample Collection to ensure correct collection of good quality samples for each test, protecting the safety of both the sample collector and patient as well as the privacy of the patient?

Activity

Does the SOP for Sample Collection include at least the following element? [tick-off]

  • Pre-collection:
    • Instructions for identification of the patient
    • Instructions to verify that the patient meets examination requirements
    • Instructions for protecting patient safety
    • Instructions for protecting safety of the laboratory staff member
    • Instructions for protecting the privacy of the patient
    • Instructions for correct treatment of the patient (with respect, friendly, and polite)
    • Instructions for information provision to the patient (what is going to happen, when can the patient expect the results and where can the patient get the results)
    • Instructions for preparation of the patient (including provision of information to the patient on sample collection and laboratory testing)
    • Guideline for completion of the Request Form, including identification of the person collecting the sample and the patient
  • Collection:
    • Instructions for correct collection of the sample, including reference to sample acceptance criteria to ensure collection of a good quality sample
  • Post-collection:
    • Procedure of labeling of the sample
    • Requirements for correct and safe packing of the sample
    • Instructions on sample transport (including time frame and temperature interval) and proper storage conditions if the sample is not transported directly after collection
    • Instructions for safe disposal of materials used for collection of the sample

Activity

Does the laboratory have an SOP for Sample Reception and Processing?

Activity

Does the SOP for Sample Reception and Processing cover the following procedures:

  • Checking sample integrity and deciding if the sample is accepted or rejected
  • Introduction of the sample into the laboratory register
  • Sample labeling
  • Sample processing
  • Procedure for processing urgent samples
  • Procedure for dealing with verbal requests
  • Periodical review of required sample volumes

Activity

Has the laboratory authorized staff members for reviewing requests and deciding which examinations must be performed?

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Has the SOP for Sample Reception and Processing been read by all relevant staff members?

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Does the laboratory use a Sample Reception Register?

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Does the Sample Reception Register leave room for including the following information:

  • Patient name + label
  • Details of requester
  • Type of primary sample
  • Date of sample collection
  • Date of sample reception
  • Date of sample acceptance
  • Examination(s) requested
  • Results of examinations + name of the laboratory technologists performing the examinations
  • Date of reporting
  • Signature and initials of person sending the report

Activity

Does the SOP for Sample Reception and Processing have an appendix with a Sample Rejection Form?

Activity

Does the Sample Rejection Form include the following elements?

  • Identification of the patient
  • Identification of the person collecting the sample
  • Identification of the clinician (if different than the person collecting the sample)
  • Identification of the sample
  • Reasons for sample rejection
  • Action to be taken (does the sample requester have to send in a new sample? Does the sample collector have to change the procedure?)

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Are copies of completed forms stored at the laboratory?

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Has the laboratory made flowcharts of all the procedures routinely being performed in the laboratory?

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Has the laboratory developed a list of all SOPs needed to standardize the entire primary process?

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Are all routinely performed procedures in the laboratory standardized in SOPs?

Take a sample by asking for several SOPs indicated in the flow charts and check the document control log of the laboratory.

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Are all SOPs complete and in line with the Master SOP, covering all required elements such as quality control, safety, tasks, authorizations and responsibilities, references, appendixes, etc.?

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